Eisai

EISAI to Unveil New Data on Halaven® (Eribulin) Mode of Action at San Antonio Breast Cancer Symposium 2015 (SABCS)

Hatfield, England (ots/PRNewswire) - PRESS RELEASE FOR EU MEDIA ONLY: NOT FOR SWISS/AUSTRIAN/U.S. JOURNALISTS

Studies at the upcoming San Antonio Breast Cancer Symposium (Texas, 8-11 December) will explore mode of action and highlight potential new combinations

New data at the San Antonio Breast Cancer Symposium (SABCS) will explore the distinct mode of action of Halaven® (eribulin) in which the epithelial-to-mesenchymal transition is reversed, the process by which cancerous cells are made more aggressive and harder to treat. The full results of the study, called "Eribulin affects E-cadherin localization consistent with a reversal of the epithelial-to-mesenchymal transition" will be presented as a poster (P5-03-09) at the conference on Friday 11 December (17:00-19:00 CST).

Eisai will present a total of seventeen eribulin abstracts at SABCS. Eribulin is currently indicated in Europe for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.[1]

A further study of stage I-II Hormone receptor positive/Her2 negative breast cancer to be presented at SABCS has data suggesting that women with the aggressive, Luminal B form of the disease might benefit the most from treatment on eribulin which induces a luminal A phenotype. The study, "Efficacy and gene expression results from eribulin SOLTI1007 neoadjuvant study (https://clinicaltrials.gov/ct2/show/NCT01669252?term=SOLTI1007+neoadjuvant+study+eribulin&rank=1)", will be presented as a poster (P3-07-66) at the conference on Thursday 10 December (17:00 - 19:00 CST).

A number of other studies to be presented at SABCS will also highlight the potential of eribulin to work in combination with other therapies. One study will present the design of a phase 1b/2 study to evaluate the efficacy and safety of eribulin in combination with pembrolizumab in patients with metastatic triple-negative breast cancer. A second study will explore whether PH20 (PEGPH20) (Pegylated Recombinant Human Hyaluronidase) enhances efficacy of eribulin in triple negative breast cancer xenografts.

The full details of the seventeen eribulin abstracts are as follows:

Abstract     Number     Abstract Name                      
Presentation Details      OT1-03-19  Design of a Phase 1b/2 
Study to          Poster Session: OT1-03-19                Evaluate 
the Efficacy and Safety of      Date: Wednesday, December 9          
Eribulin Mesylate in Combination with    Time: 5:00 PM-7:00 PM  
Pembrolizumab in Patients with                Metastatic
Triple-Negative Breast                Cancer                         
P3-07-39   CASCADE study: Treatment and clinical    
Poster Session: P3-07-39                outcomes of metastatic breast
cancer by  Date: Thursday, December 10                tumor 
immunophenotypes                   Time: 5:00 PM-7:00 PM      
OT3-02-11  Phase 2 Study Evaluating the Efficacy    Poster 
Session:OT3-02-11                and Safety of Eribulin Mesylate     
Date: Friday, December 11                             
Administered Biweekly for Subjects With  Time: 5:00 PM-7:00 PM       
Human Epidermal Growth Factor Receptor                
2-Negative Metastatic Breast Cancer          P1-12-05   Phase 2 study
of dose-dense doxorubicin  Poster Session: P1-12-05                
and cyclophosphamide followed by         Date: Wednesday, December 9 
eribulin mesylate with or without        Time: 5:00 
PM-7:00 PM                prophylactic growth factor for adjuvant    
treatment of early-stage breast cancer       P6-08-07   
Association between phenotype of triple  Poster Session: P6-08-07    
negative breast cancer cell lines and    Date: Saturday, 
December 12                sensitivity against eribulin mesylate    
Time: 7:30 AM-9:00 AM                in vitro                        
P5-03-08   Eribulin impairs the transport of        
Poster Session: P5-03-08                TGF-ss type I receptor 
leading to        Date: Friday, December 11                inhibition
of downstream non-canonical   Time: 5:00 PM-7:00 PM                
TGFss signaling necessary for cancer                metastasis and 
survival                      P5-03-09   Eribulin affects E-cadherin 
Poster Session: P5-03-09                localization 
consistent with a reversal  Date: Friday, December 11                
of the epithelial-to-mesenchymal         Time: 5:00 PM-7:00 PM       
transition                                   P1-14-04   A 
Randomized Phase II Neoadjuvant Study  Poster Session: P1-14-04      
of Sequential Eribulin Followed by       Date: Wednesday, 
December 9                FAC-Regimen Compared to Sequential       
Time: 5:00 PM-7:00 PM                Paclitaxel Followed by 
FAC/FEC-regimen                in Women with Early Stage Breast 
Cancer                Not Overexpressing HER-2                     
P6-13-17   The combination of eribulin and          Poster Session: 
P6-13-17                everolimus results in enhanced           
Date: Saturday, December 12                suppression of tumors in 
mouse models    Time: 7:30 AM-9:00 AM                of triple 
negative breast cancer             P3-07-66   Efficacy and gene 
expression results     Poster Session: P3-07-66                from 
eribulin SOLTI1007 neoadjuvant      Date: Thursday, December 10      
study                                    Time: 5:00 
PM-7:00 PM       P1-12-04   A phase 2 study of eribulin in breast    
Poster Session: P1-12-04                cancer not achieving a 
pathologic        Date: Wednesday, December 9                complete
response (pCR) to neoadjuvant   Time: 5:00 PM-7:00 PM                
chemotherapy (NAC)                           P1-14-06   A phase II 
randomized study with         Poster Session: P1-14-06               
eribulin/cyclophosphamide (ErC) and      Date: Wednesday, December 9 
docetaxel/cyclophosphamide (TC) as       Time: 5:00 
PM-7:00 PM                neoadjuvant therapy in HER2-negative       
breast cancer- Final analysis of                primary 
endpoint and correlative                analysis results             
P6-13-21   Phase 1 study of GR antagonist           
Poster Session: P6-13-21                mifepristone (M) in 
combination with     Date: Saturday, December 12                
eribulin (E) in advanced solid tumors,   Time: 7:30 AM-9:00 AM       
with dose expansion in patients (pts)                with 
GR-positive triple-negative breast                cancer (TNBC)      
P1-03-09   Pegylated Recombinant Human      
Poster Session: P1-03-09                Hyaluronidase PH20 
(PEGPH20) Enhances    Date: Wednesday, December 9                
Efficacy of Eribulin Mesylate            Time: 5:00 PM-7:00 PM       
(HALAVEN(R)) in Triple Negative Breast                Cancer 
Xenografts                                                           
OT3-02-05  Phase II study of eribulin in            Poster 
Session: OT3-02-05                combination with gemcitabine for 
the     Date: Friday, December 11                treatment of 
patients with locally       Time: 5:00 PM-7:00 PM                
advanced or metastatic triple negative                breast cancer. 
ERIGE Trial on behalf of                the Gruppo Oncologico 
Italiano di                Ricerca Clinica (GOIRC)                   
P1-10-06   Nausea control and quality-of-life       Poster 
Session: P1-10-06                benefit with NEPA, the first        
Date: Wednesday, December 9                combination antiemetic
agent, in         Time: 5:00 PM-7:00 PM                patients with 
breast cancer receiving                anthracycline/cyclophosphamide
(AC)                chemotherapy                             

Some of the information discussed in this release is about investigational uses for eribulin.

Eisai is dedicated to discovering, developing and producing innovative oncology therapies that can make a difference and impact the lives of patients and their families. This passion for people is part of Eisai's human health care (hhc) mission, which strives for better understanding of the needs of patients and their families to increase the benefits health care provides.

Notes to Editors

Eisai in Oncology

Our commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, therapeutic vaccines, and biologic and supportive care agents for cancer across multiple indications.

Halaven® (eribulin)

Eribulin is the first in the halichondrin class of microtubule dynamics inhibitors with a novel mechanism of action. Structurally eribulin is a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai. Eribulin is believed to work by inhibiting the growth phase of microtubule dynamics which prevents cell division.[1]

About Eisai Co., Ltd.

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realise our hhc philosophy by delivering innovative products in multiple therapeutic areas with high unmet medical needs, including Oncology and Neurology.

As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit http://www.eisai.com.

References

1. SPC Halaven (updated November 2015). Available at: http://www.medicines.org.uk/emc/medicine/24382 . Last accessed November 2015

Date of preparation: November 2015  Job code: Halaven-UK0452   

Contact:

Eisai
Cressida Robson / Ben Speller
+44(0)7908 314 155 / +44(0) 7908 409416
Cressida_Robson@eisai.net
Ben_Speller@eisai.net

Tonic Life Communications: Alex Davies / Deepa Patel
+44 (0)7720 496 472 / +44 (0)7725 440 867
Alex.Davies@toniclc.com
Deepa.Patel@toniclc.com

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